Joint Commission wants hand hygiene info
The Joint Commission is seeking comprehensive, innovative, and cost effective hand hygiene measurement methods that address adherence to hand hygiene guidelines to share with health care organizations throughout the world, as part of its Consensus Measurement in Hand Hygiene (CMHH) project.
The proven strategies identified through this initiative will be published in a free, educational monograph that recommends promising practices for measuring hand hygiene compliance. The monograph, planned for publication in early 2008, will be the culmination of an 18-month project by The Joint Commission in collaboration with the Association for Professionals in Infection Control and Epidemiology (APIC), the Centers for Disease Control and Prevention (CDC), the Society for Healthcare Epidemiology of America (SHEA), the World Health Organization (WHO) World Alliance for Patient Safety, the Institute for Healthcare Improvement (IHI), and the National Foundation for Infectious Diseases (NFID).
Measuring compliance with hand hygiene practices during the delivery of care has long been complicated, the commission says, because of the resources needed to monitor the practices of many different care providers in numerous locations for meaningful periods of time. The absence of standardized approaches to measuring hand hygiene performance makes it impossible to determine whether overall performance is improving, deteriorating or staying unchanged as new strategic interventions are introduced. Examples of promising practices for measuring compliance with hand hygiene guidelines are being sought from across a variety of settings, including hospitals, ambulatory care, home care, long term care, and behavioral health. Organizations submitting examples are asked to include supporting documentation, such as published studies or summaries of results regarding the use of the method, as well as a sample of data in the manner it is displayed (i.e., charts or graphs). Submissions will be confidentially reviewed by an expert panel under the direction of Professor Elaine Larson of Columbia University. If the expert panel determines that a submitted example has potential value to other health care facilities, the organization will be contacted for additional information and permission to include it in the monograph.
Examples may be submitted electronically, or by mail to Linda Kusek, Division of Research, The Joint Commission, One Renaissance Boulevard, Oakbrook Terrace, IL, 60181, or via fax to 630-792-4616. For more information, contact Kusek, project coordinator, Consensus Measurement in Hand Hygiene project, The Joint Commission, at [email protected], or telephone (630) 792-5616.
Label changes approved for Ketek
FDA says Sanofi-Aventis is revising labeling for its antibiotic Ketek (telithromycin), including removing two if its three previously-approved indications—acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis. FDA officials said they had determined that the balance of benefits and risks no longer support approval of Ketek for those indications. The drug remains available indicated for treating community acquired pneumonia of mild to moderate severity acquired outside of hospitals or long-term care facilities.
The labeling also now includes a boxed warning stating that Ketek is contraindicated in patients with myasthenia gravis.
FDA also worked with the company on development of a patient medication guide that informs patients about the drug's risks and how to use it safely. The Medication Guide is to be given to patients with each filled prescription. Other labeling changes included a strengthened warning section on specific drug-related adverse events including visual disturbances and loss of consciousness. Hepatic toxicity warnings were strengthened June 2006.
Label warning for Xolair Strengthened
FDA has asked Genentech to add a boxed warning to the product label for its Xolair (omalizumab) to emphasize that Xolair, used to treat patients with asthma related to allergies, may cause anaphylaxis. The company also was asked to revise the labeling and to prepare a patient medication guide.
Xolair was approved in 2003 to treat adults and adolescents with moderate to severe persistent asthma who have tested positive for a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled steroids.
The strengthened warning includes the possibility of patients developing anaphylaxis after any dose of Xolair, even if there was no reaction to the first dose. Also, it says, anaphylaxis after Xolair administration may be delayed up to 24 hours after the dose is given.
Manufacturers of drugs used to treat attention deficit hyperactivity disorder (ADHD) were told by FDA to develop patient medication guides to alert patients to possible cardiovascular risks and risks of adverse psychiatric symptoms and to advise them of precautions that can be taken. Officials said an agency review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.
They said another review revealed a slight increased risk for drug-related psychiatric adverse events such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.
FDA recommended that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other healthcare professional on developing a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems.
The Joint Commission is seeking comprehensive, innovative, and cost effective hand hygiene measurement methods that address adherence to hand hygiene guidelines to share with health care organizations throughout the world, as part of its Consensus Measurement in Hand Hygiene (CMHH) project.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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